Post navigation

In the second half of 2016, two very interesting decisions were issued by the federal courts in Brazil against the Brazilian Food and Drug Agency (ANVISA) involving the prior approval of patent applications claiming pharmaceutical products.These decisions bring some very good news to pharmaceutical patent owners who have struggled for years with ANVISA while trying to protect their pharmaceutical patents in this country.

In the decisions, Genentech and Novartis each obtained preliminary injunctions against ANVISA in cases of prior approval of their patent applications under Article 229-C of the Brazilian Patent Statute (Additional information about each of the decisions can be found here:novartisdecisiongenentechdecision).Specifically, Novartis’ patent application claims fingolimod (Gilenya) and Genentech’s application claims bevacizumab (Avastin).

Two different trial judges affirmed that ANVISA did not have the authority to examine patentability requirements under Article 229-C of the Patent Statute. In the decision involving Genentech’s application, the judge, the Honorable Diana Silva, limited ANVISA’s role during the prior approval process to only aspects involving public health. The decision also stated that the Brazilian Patent and Trademark Office, namely, the Instituto Nacional da Propriedade Industrial (INPI)is the sole legitimate agency to examine the patentability requirements of patent applications directed to pharmaceutical products.

The decision involving Novartis’ application is an important case for pharmaceutical companies facing the issues of backlog and pendency of their patent applications in Brazil. Specifically, in this case, Novartis sought a preliminary injunction against ANVISA, claiming that the agency was taking an unreasonable amount of time to issue a decision regarding prior approval.Additionally, Novartis also requested preventive measures against the agency to prevent it from examining the application for compliance with patentability requirements under the Brazilian Patent Statute (which is the function of INPI).The judge, the Honorable Iolete Oliveira, accepted Novartis’ arguments and granted a preliminary injunction ordering ANVISA to:(1) analyze the prior approval of the patent application within 15 days; and (2) abstain from examining the application for compliance with any patentability requirements but focus instead only on aspects of public health.

Both of these decisions highlight that the Brazilian federal courts are willing to limit ANVISA’s role under the prior approval analysis. The Novartis case establishes important precedent that can be used by other companies currently waiting ANVISA’s decision on prior approval analysis.

On December 2, 2016, the Delhi High Court struck down Section 24(5) of the Plant Varieties and Farmers Rights Act, 2001 (Act) as unconstitutional in Prabhat Agri Biotech Ltd. et al. v. Registrar of Plant Varieties. As will be discussed in more detail below, the Court held that Section 24(5) violated Section 14 of the Constitution of India. Specifically, the Court held that this section of the Act gave unbridled power to the Register, who was not required to have a legal background or possess any legal expertise, to grant interim relief to a breeder against any abusive third party act occurring during the pendency of an application for registration of a variety.

Background

The Protection of Plant Varieties and Farmers Rights Act, 2001 (Act) was passed in 2001 and went into effect in November 2005. The stated rational of the Act is to establish a system for the protection of plant varieties, rights of farmers and plant breeders as well as encourage the development of new plant varieties in India. Additionally, the Act is intended to provide the protection needed to facilitate the growth of the seed industry in India, ensure the availability of high quality seeds and planting material for farmers as well as protect plant breeders’ rights for accelerated agricultural development within the country.

Section 12 of the Act establishes the Plant Varieties Registry (Registry) to facilitate the registration of varieties while also providing for the appointment of as many registrars (Registrars) as necessary to allow for the registration of such varieties. Section 13 of the Act provides for the maintenance by the Registry of a register called the “National Register of Plant Varieties” (Register). The purpose of the Register is to record the names of all registered plant varieties along with the names and addresses of the respective breeders, the right of such breeders in their registered varieties, the particulars of the denomination of each registered variety, its seed or other propagating material along with specification of the salient features and any other information which may be required for registration of the variety.

Section 2 of the Act provides a number of definitions of key terms that are used throughout the Act. For example, Section 2(za) defines a “variety” as a “plant grouping except a microorganism within a single botanical taxon of the lowest known rank, which can be:

(i) Defined by the expression of the characteristics resulting from a given genotype of that plant grouping;
(ii) Distinguished from any other plant grouping by expression of at least one of said characteristics; and
(iii) Considered as a unit with regard to its suitability for being propagated, which remains unchanged after such propagation,
and includes propagating material of such variety, extant variety, transgenic variety, farmers’ variety and essentially derived variety.”

Section 2(i) defines an “essentially derived variety”. Specifically, this section states that a variety (the initial variety), shall be said to be essentially derived from such initial variety when it:

(i) “is predominantly derived from such initial variety, or from a variety that itself is predominantly derived from such initial variety, while retaining the expression of the essential characteristics that results from the genotype or combination of genotype of such initial variety;
(ii) is clearly distinguishable from such initial variety; and
(iii) conforms (except for the differences which result from the act of derivation) to such initial variety in the expression of the essential characteristics that result from the genotype or combination of genotype of such initial variety.”

Section 2(j) defines “extant variety” as a variety available in India which is:

(i) “notified under section 5 of the Seeds Act, 1966 (54 of 1966); or
(ii) farmers’ variety; or
(iii) a variety about which there is common knowledge; or
(iv) any other variety which is in public domain”.
(v)
Section 2(k) defines “farmer” as any person who:
(i) “cultivates crops by cultivating the land himself; or
(ii) cultivates crops by directly supervising the cultivation of land through any other person; or
(iii) conserves and preserves, severally or jointly, with any person any wild species or traditional varieties or adds value to such wild species or traditional varieties through selection and identification of their useful properties.”

Section 2(l) defines a “farmers’ variety” as a variety which:
(i) “has been traditionally cultivated and evolved by the farmers in their fields; or
(ii) is a wild relative or land race of a variety about which the farmers possess the common knowledge”.

A variety can be registered by submission of an application to the Registrar. According to Section 16 of the Act, an application can be submitted by any “person”. A “person” includes:

(i) any person claiming to be the breeder of the variety; or
(ii) any successor of the breeder of the variety; or
(iii) any person being the assignee of the breeder of the variety in respect of the right to make such application; or
(iv) any farmer or group of farmers or community of farmers claiming to be the breeder of the variety; or
(v) any person authorized in the prescribed manner by a person specified under items (i) – (iv) to make application on his behalf; or
(vi) any university or publicly funded agricultural institution claiming to be the breeder of the variety.

Section 18 describes the specific technical and other information that must be included in each application. According to Section 15, once an application has been submitted, a variety can be registered only if it satisfies the criteria of novelty, distinctiveness, uniformity and stability. During the examination process, the application can be amended if requested by the Registrar. Once an application is accepted, it is published for opposition. If no opposition is filed or if an opposition is rejected, the Registrar will register the variety and issue a certificate. If the certificate issued is for an essentially derived variety, the certificate is valid for nine years from the date of registration for trees and vines and six years from the date of registration for all other plants (which is renewable). However, , the total period of validity of a registration cannot exceed:

(i) eighteen years from the date of registration for trees and vines;
(ii) fifteen years from the date of the notification of that variety by the Central Government under section 5 of the Seeds Act, 1966 (54 of 1966) for extant varieties; and
(iii) fifteen years from the date of registration of a variety in all other cases.

According to Section 28(1) of the Act, a certificate confers an exclusive right on the breeder or his successor, agent or licensee, to produce, sell, market, distribute, import or export the variety. One interesting provision of the Act, which will be discussed in more detail below, is Section 24(5) which gives the Registrar the “power to issue such directions to protect the interests of a breeder against any abusive act committed by any third party during the period between filing of application for registration and decision taken by the Authority on such application”.

Prabhat Agri Biotech Ltd. et al. v. Registrar of Plant Varieties

The petitioners, Prabhat Agri Biotech Ltd. (Prabhat), Nuziveedu Seeds (Nuziveedu) and Kaveri Seed Company Ltd. (Kaveri), challenged the vires of Section 24(5) of the Act. Nuziveedu, a sister company to Prabhat, had, over the course of several years, various hybrid and parental cotton lines copied from one of the respondents, Maharashtra Seeds (Maharashtra). In fact, Maharashtra filed an application to register a hybrid variety of cotton which was alleged to have been developed using Nuziveedu’s proprietary parent lines. After filing its application, Maharashtra filed an application under Section 24(5) against Prabhat and Nuziveedu. The third petitioner, Kaveri, was not subject to an application under Section 24(5) by any third party.

During the proceeding, the Solicitor General, on behalf of the government of India, argued that Section 24(5) was necessary for the public interest. Specifically, the Solicitor General argued that this section of the Act was based on Article 13 of the International Convention for the Protection of New Plant Varieties, 1991 (UPOV), which necessitated Article 24(5) because it obligated parties to take suitable steps to safeguard the rights of applicants during the period during which their application was under evaluation. Specifically, the Solicitor General pointed to the statements in Article 13 of UPOV which states:

“Each Contracting Party shall provide measures designed to safeguard the interest of the breeder during the period between the filing or the publication of the application for the grant of a breeder’s right and the grant of that right. Such measures shall have the effect that the holder of a breeder’s right shall at least be entitled to equitable renumeration from any person who, during the said period, has carried out acts which, once the right is granted, require the breeder’s authorization as provided in Article 14. A Contracting party may provide that the said measures shall only take effect in relation to persons whom the breeders has notified of the filing of the application.”

According to the Solicitor General, Section 24(5) was based on sound public policy due to the fact that Article 13 of UPOV required a measure of interim protection. As a result, Section 24(5) had to be enacted.

In its decision, the Court stated that the power conferred upon the Registrar in Section 24(5), namely, the ability to make an interim order anytime during the pendency of an application, was simply too broad. Specifically, the Court stated:

“…its exercise is not in any manner conditioned upon consideration of any objective material. The only guidance given in the section was that such an order could be made if a person were engaged in an ‘abusive act’”.

According to the Court, an “abusive act” contemplated a range of behaviors from suspicion of infringement or use of someone’s material to the genuine use of material legitimately developed by a rival. As such, the Court stated:

“In other words, ‘abuse’ is not only wide and vague in its import, but ‘abuse’ by which entity – a specified third party, or generically all other parties (consider third parties) in the subject-object verb relationship sharpens the concern that the power (to issue interim orders) is overbroad and without any guidance. To illustrate, an abuse could be a case of theft of variety and its exploitation by sale; if demonstrable, that it is an abuse might be capable of injunctive relief. However, at the other end of the scale, if there is no theft or allegation of theft but rather claim by the applicant that it has developed the variety first and is, therefore, entitled to protection as opposed to the assertion of a rival that such a position is incorrect and the variety is an extant one, or a farmers’ variety, a possible view can be that use by such rival of the variety is an abusive act. Therefore, the basis for grant of an order under the impugned provision is existence of a vague and undefined state of affairs.”

The Court noted that the Act clearly provided the conditions that an applicant had to fulfill to secure the registration of a new variety. In contrast, the Act was less than clear and even vague in terms of what a Registrar had to scrutinize when deciding whether or not to grant interim relief under Section 24(5). What seemed to trouble the Court was the fact that the power of Section 24(5) was exercisable at any stage, even the moment after an application was filed, regardless of the merits of the case (namely, whether the applicant claimed to be a breeder or farmer of even if the variety was entitled to protection).

Additionally, the Court was further troubled by the fact that while the Act clearly spelled out the rights and obligations of the applicants, the qualifications to be fulfilled and the conditions to be made as well as the various steps involved in the granting or refusal of an application, it failed to specify the requirements and/or qualifications of individuals suitable to hold the office of Registrar. In fact, the Court noted that there was nothing in the Act that required that the Registrar have any judicial or quasi judicial expertise. In view thereof, according to the Court, it was constitutionally impermissible to give the Registrar the power to make significant legal determinations such as those contemplated under Section 24(5) given the potentially far-reaching implications.

The Court concluded stating:

“Given the importance of the Act, there is enormous danger in empowering authorities with unguided and uncanalized power through provisions that can implicate livelihoods and limit or impair food access to tens of thousands – potentially hundreds of thousands of farmers and users of plant varieties. The existence of a large section of farmers unschooled in the provisions of the Act and unaware of their rights renders unethical bioprospecting practices and spurious claims to development of new or other registrable varieties, entitled to registration, a real possibility. Section 24(5) of the Protection of Plant Varieties & Farmers’ Rights Act as cast as present may undoubtedly be an adequate remedy to prevent abusive practices (assuming that what is abusive can be defined over a period of time); yet the danger of abuse of the provision itself and the attendant (likely) long term injury to innocent breeders, framers and those in the business of development of hybrids and plant varieties far outweighs its benefits, in view of the unguided nature of the power, which is destructive of the rule of law and contrary to Article 14 of the Constitution of India. Section 24(5) of the Protection of Plant Varieties and Farmers’ Rights Act, 2001, is, therefore, declared void.”

On November 27, 2016, China released a guideline outlining steps for the “better” protection of property rights (Guideline).The Guideline is referred to as the “Opinion of the Central Committee of the Communist Party of China (CRC) and the State Council on improving the property rights protection (PRP) system and lawfully protecting property rights”.Property rights in China include creditor’s rights, stock rights and intellectual property rights.

The Guideline is the first state-level guideline on property rights protection and its purpose is to raise social confidence and promote justice in China.While not rule of law, the Guideline is important as it is a centrally-issued policy.Policy plays an enormously important and influential role in China and embodies and conveys certain values and often obtains broad results relatively quickly while final law is promulgated.

According to the Guideline, China will provide equal, comprehensive and law-based protection to all kinds of property rights, including intellectual property, and encourages the participation of the public in the process. Although China has worked over the years to improve property rights, many problems still exist, including infringement on private property by public power (governments) and weak enforcement of intellectual property rights.The Guideline states that securing property rights will help raise the public’s sense of wealth security, raise social confidence, foster positive expectations while raising the “impetus for entrepreneurship and innovation by various economic entities”.Moreover, the Guideline further notes that improving such protection will facilitate social justice while maintaining healthy economic and social development.

According to the Guideline, the “essential strategy” that will be used to strengthen PRP is to “comprehensively” promote the “Rule of Law” (rather than the “Rule of Men”).As a result, ten (10) tasks will be carried out.One of these tasks involves reinforcing intellectual property (IP) rights (IPRs).With respect to IPRs, the Guidelines lists several sub-tasks that need to be completed.These include:

1.Increasing punishment for infringement of IPRs as well as the upper limits of damages available once liability for such infringement has been established.The Guideline states that the concept of punitive damages should be explored and established.Moreover, compensation for infringement should also cover the reasonable expenses paid by the patent holder to stop the infringement.

2.Establishing a mechanism to collect information on the source of counterfeit products.Additionally, companies and individuals found to have infringed IPRs will have such information incorporated into their credit records.Finally, improving the transparency of IP related administrative punishment procedures will be promoted.

3.Improving the procedures of IPR trials and actively increasing the role of the intellectual property courts.Moreover, the Guideline suggests consolidating three judicial procedures (civil, criminal and administrative) into one system to enhance the cooperation between administrative and criminal enforcement.

4.Improving the enforcement mechanisms for foreign-originated intellectual property.Specifically, the Guideline suggests strengthening the international cooperation of criminal enforcements and the intensity of investigations.The Guideline suggests severely punishing those engaging in unfair competition in order to strengthen brand protection.Finally, the Guideline suggests the combination of IP protection in IPR utilization in order to speed up IP transfer and transformation.

It appears that courts in China are already beginning to implement some of the tasks outlined in the Guidance.On December 8, 2016, the Beijing Intellectual Property Court (Court) issued a decision in favor of the patentee in a patent infringement action involving a patent claiming a USB key used by banks.In its decision, the Court agreed with patentee’s claimed damages of 50 million RMB (about $7,241,969 U.S. dollars (USD)), including damages of 48,142,000 RMB (about $6,972,857 USD) calculated by multiplying the amount of each infringing product by a reasonable profit for each product, inferred damages of 858,000 RMB (about $124,272 USD) resulting from the defendant refusing to submit evidence of the volume of its sales as well as reasonable expenses of 1 million RMB (about $144,839 USD) incurred by the patentee in enforcing the patent.

Please continue to watch the BRIC Wall Blog for further updates on the implementation of the Guidance in China.

As discussed in our July 2015 post, the Canadian Intellectual Property Office (CIPO) released Practice Notice PN2015-02 (Practice Note), which instructed examiners to use an application’s description and the common general knowledge to identify an unaddressed “problem” and its proposed “solution”.

A determination of whether a diagnostic method claim is patent eligible is made based on the essential elements as determined through a purposive construction of the claim. A proper purposive construction is a two-step analysis requiring an Examiner to identify (1) the problem the inventors set out to solve; and (2) the solution disclosed.

For diagnostic methods, only two types of mutually exclusive problems are recognized: data acquisition problems and data analysis problems. “Data acquisition” problems involve, for example, identifying, detecting, measuring, etc., the presence or quantity of analyte X in a sample, while “data analysis” problems involve, for example, analyzing the significance of the acquired data (such as how the presence, increase/decrease in quantity, etc., of analyte X correlates to condition Y).

The Practice Notice indicates that the “essential elements” of a claim are limited to those that work together to solve this restricted problem. Other “non-essential” claim elements are said to “merely define the context or the environment of a specific working embodiment, but do not actually change the nature of the solution to the problem…” These non-essential elements are excluded from later analysis.

The Practice Notice suggests that “data analysis” solutions will generally be viewed as unpatentable, particularly when the identified solution is only provided by an element or set of elements associated with the analysis or significance of acquired data. The CIPO views that the recitation of only data analysis elements that are disembodied (e.g., mental process, lacking physicality, or having no physical application) is insufficient to meet the subject matter eligibility criteria of the Patent Act.

In contrast, the Practice Notice indicates that a claim having a physical step of data acquisition as an essential element likely will be found patent eligible. The Practice Notice provides the following examples as to elements expected to be characterized as “data acquisition”:

detecting protein X in a subject sample;

measuring the concentration of substrate X;

determining the expression levels of genes A, B and C;

contacting a urine sample with antibody A and determining the optical density; and

incubating a sample with a nucleic acid probe consisting of SEQ ID NO: 1 and detecting hybridization between the probe and target sequence A.

The application of these restrictive guidelines had created what some Canadian practitioners see as a hostile situation for diagnostic claims in Canada. Indeed, Access to Information requests from the biotechnology industry reveal significant discord within the biotechnology examining division in CIPO, leading to examination of hundreds of diagnostic patent applications being placed on hold as CIPO works to develop its policy. These developments suggest that CIPO’s position may be challenged in court. In the meantime, applicants should argue against objections raised by CIPO under section 2 until clarity is obtained from the courts.

USPTO Subject Matter Eligibility Guidance

In view of the restrictive climate at CIPO, we at the BRIC Wall thought it would be insightful to update our analysis of subject matter eligibility under Canadian patent law for diagnostic method claims based on the USPTO’s May 2016 updated Guidance and Life Science examples for evaluating subject matter eligibility under Section 101 (Guidance).

On July 16, 2016, the USPTO issued a memo commenting on recent decisions by the U.S. Supreme Court (Supreme Court) and the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in two subject matter eligibility cases concerning life sciences method claims: Sequenom v. Ariosa and Rapid Litigation Management v. CellzDirect, respectively. The memo concludes that neither decision changes the subject matter eligibility framework and that the existing Guidance and training examples are consistent with these cases; however, the memo also notes that the Rapid Litigation Management decision further clarifies the inquiry involved in determining whether a claim is directed to a judicial exception. In particular, the Federal Circuit stated that the “directed to” analysis of a process claim requires more than “merely identify[ing] a patent-ineligible concept underlying the claim” and instead requires an analysis of whether “the end result of the process, the essence of the whole, was a patent-ineligible concept.”

The May 2016 Update provided more detailed instructions for Examiners regarding the formulation of a rejection under Section 101 and evaluation of an Applicants response thereto. Specifically, Examiner’s must identify the exception to patentable subject matter (referred to as a “judicial exception”) that is being claimed, explain what is recited in the claim and why it is an exception, and identify any additional elements that define claim features/limitations/steps that are beyond the exception. The Examiner must then explain why the additional elements individually AND in combination do not result in the claim as a whole amounting to “significantly more” than the exception.

The May 2016 update also provided additional examples for application of the Guidance to specific types of life science claims, which were not well represented in the previous USPTO Guidance.

Analysis of Life Sciences Examples from May 2016 Update to USPTO Guidance

Example 29 – Diagnosing and Treating Julitis

Background: Example 29 of the May 2016 Update relates to a hypothetical situation relating to an autoimmune disease called “Julitis.” An applicant for a patent discovered that Julitis could be diagnosed by detecting the presence of the hypothetical “JUL-1” protein in patients’ plasma, skin, hair and nails. Applicant has disclosed detecting JUL-1 using anti-JUL-1 antibodies that may be naturally occurring (e.g., a human anti-JUL-1 antibody isolated from a patient known to have julitis), or non-naturally occurring (e.g., a porcine anti-JUL-1 antibody created by injecting pigs with JUL-1, or a specific monoclonal antibody named “mAb-D33”).

Two representative claims from this Example are analyzed below.

Claim 1. A method of detecting JUL-1 in a patient, said method comprising:

obtaining a plasma sample from a human patient; and

detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

Claim 2. A method of diagnosing julitis in a patient, said method comprising:

obtaining a plasma sample from a human patient;

detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and

diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

Analysis of claims 1 and 2: Claims 1 and 2 would likely constitute patent eligible subject matter in Canada, although an Examiner may require the recitation of a specific anti-JUL-1 antibody (e.g., by SEQ ID NO). However, one caveat is that the “obtaining” steps in claims 1 and 2 might be considered a medical treatment step thus rendering the claim ineligible on that basis alone. In the event such a rejection were raised, it could be overcome by removing this step or making the step of obtaining the plasma sample inactive (such as by reciting a specific anti-JUL-1 antibody).

In the U.S., claim 1 constitutes patent eligible subject matter, while claim 2 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the claim is directed to a judicial exception (i.e., the correlation between the presence of JUL-1 and the presence of julitis in the patient) and as a whole does not amount to significantly more than the exception itself.

Example 31 – Screening for Gene Alterations

Background: Applicant discovered the “wild-type” sequence of the human BRCA1 gene (i.e., the typical sequence of the gene in humans), and has also discovered naturally occurring alterations from the wild-type sequence that are correlated with an increased likelihood of developing breast or ovarian cancer. Applicant’s disclosure provides methods of screening patients for alterations in the BRCA1 gene by comparing a patient’s BRCA1 sequence with the wild-type BRCA1 sequence. The compared sequences can be germline (genomic) DNA sequences, RNA sequences, or cDNA sequences.

At the time the invention was made and the application was filed, scientists routinely compared DNA sequences using two-data generating techniques: (1) hybridizing two different DNA molecules (e.g., a probe and DNA isolated from a patient sample), and detecting whether the molecules bind to each other and form a hybridization product and (2) amplifying (making copies of) at least part of a DNA molecule such as DNA isolated from a patient sample, by using a set of primers to produce amplified nucleic acids, and then sequencing the amplified nucleic acids. The probes and primers used in these techniques are short single-stranded DNA molecules that typically have a naturally occurring nucleotide sequence.

In one embodiment, applicant discloses using a computer-implemented micromechanical method known as Scanning Near-field Optical Microscopy (SNOM) to detect hybridization of a single probe to its target. At the time the invention was made and the application was filed, the use of SNOM to study DNA hybridization had been discussed in several articles in widely-read scientific journals. However, scientists were not commonly or routinely using SNOM to study DNA hybridization at the time the invention was made and the application was filed. Instead, scientists at the time typically used autoradiography to detect hybridization products.

In another embodiment, applicant discloses using Cool-Melt polymerase chain reaction (Cool-Melt PCR) to amplify BRCA1 DNA from the patient sample. Cool-Melt PCR uses lower melting and annealing temperatures than conventional PCR, which results in Cool-Melt PCR having a 20-fold higher sensitivity of mutation detection than conventional PCR. At the time the invention was made and the application was filed, Cool-Melt PCR was known and used by a few scientists in the field. Several years after filing the application, Cool-Melt PCR became a standard laboratory technique that appeared in virtually every laboratory manual and was conventionally used by most scientists in the field to amplify mutant nucleic acids.

Three representative claims from this Example are analyzed below.

Claim 1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

amplifying by Cool-Melt PCR all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids; and

sequencing the amplified nucleic acids.

Analysis of claims 1, 70, and 80: Claim 1 would not constitute patent eligible subject matter in Canada (relates to a “data analysis” problem), while 70 and 80 would constitute patent eligible subject matter in Canada (relate to a “data acquisition” problem). In the U.S., claim 1 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the “comparing” amounts to an abstract idea, which is a judicial exception, and the claim as a whole does not amount to significantly more than the exception itself. In contrast, claims 70 and 80 are patent eligible in the U.S., as each claim recites additional elements that distinguishes the claim from well-understood, routine, or conventional techniques in the field (i.e., SNOM and Cool-Melt PCR, respectively), and, therefore, each of claims 70 and 80 as a whole amounts to significantly more than the exception itself.

In view of the above, it is clear that the current standard for determining patent eligible subject matter in Canada based on CIPO’s Practice Notice is similarly restrictive to the patentability of diagnostic method claims as compared to U.S. patent law. The BRIC Wall Blog will continue to monitor the fate of diagnostic claims in Canada.

This post was written by Melissa Kolom & Lisa Mueller of Michael Best and Trevor Newton of Gowlings WLG (Canada)

Brazil’s Biodiversity Law No. 13,123 (Biodiversity Law) was signed into law on May 20, 2015. Decree No. 8,772 (Decree) was issued on May 11, 2016 to implement the statute which repealed provisional measure 2,186-16 adopted by President Fernando Henrique Cardoso in 2001 (2001 Provisional Measure). The 2001 Provisional Measure has been criticized as overly complex and bureaucratic. Nonetheless, one of the consequences of the Biodiversity Law and the Decree was the creation of several new obligations relating to the research and development of plant varieties in Brazil, particularly those resulting from the access to national genetic heritage and associated traditional knowledge.

As a result, on October 24, 2016, the Brazilian Plant Variety Protection Office (PVP Office) implemented several new procedures relating to the filing and examination of PVP applications in order to comply with the provisions of the Biodiversity Law and Decree. These new procedures can be found in English here: englishpvpprocedures.

One of the new procedures is the requirement of a declaration of access or non-access to national genetic heritage samples or associated traditional knowledge (access declaration) that might have occurred during the development of a new plant variety. An access declaration must be submitted for any new plant variety that resulted from research where access to Brazilian genetic heritage or associated traditional knowledge might have occurred as of June 30, 2000. For new applications, an access declaration will be required at the time of filing of an application. The same applies for pending applications. The PVP Office will issue an Office Action requiring the submission of the declaration before granting protection.

The PVP Office has proposed two different wordings for an applicant’s access declaration: (i) “The applicant declares that a genetic heritage or a traditional knowledge were accessed for the present protection request”; and (ii) “The applicant declares that neither a genetic heritage nor an associated traditional knowledge were accessed for the present protection request”.

In those instances where access to national genetic heritage samples occurred during the development of a new variety, the applicant must register the new variety at the Board of Management of Genetic Heritage – Brazilian Ministry of Environment (CGEN) prior to the filing of a PVP application. Failure to do so will result in the shelving of the application by the PVP Office (Article 110 of the Decree). Moreover, information relating to the registration at CGEN must be submitted at the time of the filing of the application along with the access declaration. Despite having an integrated system, the Ministry of Agriculture’s CGEN electronic filing of documents is not yet available. The PVP Office has stated that Articles 37 and 38 of the Biodiversity Law will be disregarded and applicants will have more time than the one (1) year transitional period to provide the registration information to the office.

Any use of associated traditional knowledge requires prior and informed consent from the native community providing such knowledge (Article 9 of the Biodiversity Law). Specifically, the community must be made aware of the social, cultural and environmental impact of providing such knowledge and must also be informed that it has the right to refuse the users access request (Article 16 of the Decree).

Applicants must comply with every requirement of the Biodiversity Law and Decree. Violations can result in several administrative sanctions, including fines, cancellation or shelving of an application, product seizure, interdiction of the offending applicant, etc. Specifically, the fines provided by the Decree are as follows:

Accessing traditional knowledge without the community’s prior approval: From approximately USD 30,000 to approximately USD 3 million (Article 83 of the Decree);

Failure to notify the CGEN of the marketing of finished products or reproductive materials: From approximately USD 9,000 to approximately USD 3 million, which can be doubled in case of international marketing (Article 78 of the Decree);

Sending genetic heritage abroad (outside of Brazil) without previous registry: From approximately USD 30,000 to approximately USD 3 million, which can be tripled in the case endangered species are used (Article 79 of the Decree);

Filing for patents in Brazil or abroad without previous registry: From approximately USD 6,000 to approximately USD 3 million (Article 80 of the Decree);

Disclosing results without previous registry: From approximately USD 15,000 to approximately USD 150,000 (Article 81 of the Decree); and

Failing to register the access before the marketing of intermediary products: From approximately USD 15,000 to approximately USD 150,000 (Article 82 of the Decree).

Access and benefit sharing (ABS) agreements are required for any economic use of varieties originating from access to genetic heritage or associated traditional knowledge. ABS agreements are mandatory, even if the new variety is manufactured abroad. The ABS agreements fall into two categories:

Financial: Requirement of payment to the National Fund for Benefit Sharing (FNRB) of 1% of the annual net income originating from the economic use of the genetic heritage. This amount may be reduced by up to 90% (0.1% of the net income) by filing a petition before the Environment Ministry (MMA); and

Non-financial: Technology transfer, disclosure of the product to public domain, royalty-free licensing, etc.

The BRIC Wall blog has been nominated for The Expert Institute’s 2016 Best Legal Blog Contest. This year, more than 500 finalists have been identified as the “most exciting, entertaining, and informative legal blogs online today,” by The Expert Institute, and the BRIC Wall Blog has been included as a leader in the Best AmLaw Blogs category.

During the last two years, there has been a lot of interest and discussion about compulsory licenses in Colombia, particularly with respect a patent covering the beta polymorph of imatinib mesylate (imatinib), which is marketed by Novartis as Gleevec® or Glivec. In this post, the BRIC Wall Blog looks at compulsory licenses in Colombia and the Glivec case in detail.

Compulsory licenses in Colombia – Background

In Colombia, a compulsory license may be granted:

Three years following grant of a patent or four years following filing of a patent application, whichever is longer, if the patent has not been worked in Colombia or if working of the patent has been suspended for over one year, unless the patent owner is able to provide a valid reason(s) for its failure not to work the invention (such as, for example, force majeure, an act of God, etc.). Additionally, a compulsory license will only be granted if the third party applying for the license has made an effort to obtain a license from the patent owner on commercially reasonable terms and such efforts were not successful (Articles 61-64 of Decision No. 486 of the Andean Community Commission Establishing the Common Industrial Property Regime (Decision)).

Upon declaration of the existence of a public interest, an emergency, or other national security considerations. When a compulsory license is granted for one of these reasons, the patent is subject to the compulsory license only for so long as the considerations exist. The Colombian Patent Office (CPO) will establish the scope of the license, specify its duration and the compensation to be paid to the owner (Article 65 of the Decision). In Colombia, the declaration is made by the Ministry in charge of the subject matter of the patent; e.g. by the Ministry of Health (MoH) for pharmaceutical patents. Once the declaration is made, the case is handed over to the CPO (part of the Superintendence of Industry and Commerce) to determine the terms of the compulsory license and to process the specific compulsory license request under those terms.

By the CPO ex officio or at the request of a third party and after receiving the consent of the national antitrust authority, in situations where the practices of the patent owner are deemed to be detrimental to the exercise of free competition, particularly where they constitute an abuse by the patent owner of a dominant position in the market (Article 66 of the Decision).

Upon request of a patent owner in situation where exploitation of its patent (the “first patent”) requires a license to another patent (the “second patent”) and the patent owner has been unable to obtain a license to the second patent on commercially reasonable terms (Article 67 of the Decision). Compulsory licenses granted under these circumstances are subject to the following conditions:

The invention claimed in the second patent must constitute an important technical advance of considerable economic significance in relation to the invention in the first patent;

The owner of the first patent is entitled to a cross-license on reasonable terms to use the invention claimed in the second patent; and

The license authorized in connection with the first patent is non-assignable except when the second patent is assigned.

All compulsory licenses granted in Colombia are subject to the following general conditions:

Before the grant of a compulsory license, the patent owner is notified and provided with a deadline of 60 days to submit arguments;

Are non-exclusive and cannot be sublicensed;

The licensee must work the object of the license within two years after grant, unless reasons of force majeure are proven;

Compulsory licenses do not exclude the patent owner from working the patent;

Are non-assignable, except in connection with the part of the business or goodwill which permits its industrial use. Any such assignments must be in writing and registered before the CPO, otherwise such transfers shall not be considered legally binding;

Are terminable if and when the circumstances which led to the granting of the compulsory license cease to exist and are unlikely to recur;

The scope and duration of any compulsory license shall be limited to the purposes for which they were authorized;

For patents protecting the semi-conductor technology, a compulsory license shall be authorized only for public non-commercial use or to remedy a practice declared by the competent national authority to be anti-competitive pursuant to Articles 65 and 66;

Must provide for the payment of adequate remuneration pursuant to the circumstances of each case, taking into account the economic value of the license (without prejudice to the stipulations provided for in Article 66); and

Must be used predominantly for the supply of the Colombian market.

Compulsory Licenses Granted on Public Interest Grounds

In Colombia, there have been two compulsory licensee cases on public interest grounds. In both cases, the compulsory licenses were initiated by the same non-governmental organizations, namely, IFARMA Foundation, Mision Salud and CIMUN (collectively, NGOs). In both cases, the compulsory licenses were rejected. However, in both cases, price cuts were implemented or being sought.

The first compulsory license case began in 2008 and involved Kaletra®, marketed by Abbott Laboratories. Kaletra® is an anti-retroviral medicine containing ritonavir and lopinavir and is used in the treatment of HIV/AIDS. Although the MoH rejected the declaration of public interest and therefore, the compulsory license, the Colombia government cut the price of Kaletra® by 55%.

The most recent case involved Novartis’ Glivec product. In November 2014, the NGOs began encouraging the MoH to declare access to Glivec to be of public interest with the goal of securing a compulsory license. Glivec costs about twice the average Colombian income of $15,000 per year.

Not surprisingly, the attempt by the Colombian organizations to secure a compulsory license were met with resistance and response from a variety of players including developed countries, Big Pharma and Colombian trade authorities. As a result, the NGOs sent a letter in May 2016, to the Chairman of the World Health Organization 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) alleging that the enormous pressure was being applied by those opposing the compulsory license that combined “inaccuracies, distortions of international trade rules and even threats of trade claims under the dispute settlement mechanism”. Adding more fuel to the fire, also in May 2016, a letter was sent by 28 organizations to President Obama that expressed concern access to medicine and U.S. aid to support peace in Colombia. Moreover, still also in May 2016, a letter was sent to Columbia President Manuel Santos by lawyers, academics and other experts specializing in intellectual property and health encouraging his administration, the MoH and the Superintendence of Industry and Commerce to proceed with the public interest declaration and grant the compulsory license for imatinib.

On June 14, 2015, Alejandro Gaviria, Health Minister of the MoH, issued Resolution No. 2475 declaring the existence of public interest for imatinib. However, this resolution did not order the issuance of a compulsory license for Glivec but instead requested that the National Price Pharmaceutical Commission (NPCC) provide a new price methodology for Glivec (which had already been included in the Price Regulation Regime; and, additionally, the price of Glivec, had already been regulated twice in the past). The new methodology, proposed in a NPPC draft circular (directive), stated that the maximum price for a drug subject to a declaration of public interest would be equal to the lowest price of any competitor in any referenced country. A “referenced country” comprises 17 countries. This circular (directive) is still in a preliminary stage.

Please continue to watch the BRIC Wall Blog for more updates on compulsory licenses in Colombia.

This post was written by Lisa Mueller and Alexander Agudelo of Olarte Moure.